Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03668704
• Other study ID #: 003
• Status: Active, not recruiting
• Start date: April 2013
• Est. completion date: April 2026

Study information

• Verified date: September 2018
• Source: St. Helena Hospital Coon Joint Replacement Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Description:

The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.

• Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.

• Patient is willing to comply with follow up

Exclusion Criteria:

• Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.

• Patient had active infection

• Implants were implanted without bone cement

• Patients did not have sufficient bone stock to allow for insertion and fixation of components

• Patient did not have sufficient soft tissue integrity to allow for stability

• Patient had a neurological or muscular deformity that did not allow for control of the knee.

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	St. Helena Hospital Coon Joint Replacement Institute	Saint Helena	California

Sponsors (2)

Lead Sponsor	Collaborator
St. Helena Hospital Coon Joint Replacement Institute	Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	% of patients with revisions	To determine the revision rate in this patient population	5 years after surgery
Other	% of patients with revisions	To determine the revision rate in this patient population	7 years after surgery
Primary	% of patients with Revisions	To determine the revision rate in this patient population	10 years after surgery
Secondary	% of patients with Revisions	To determine the revision rate in this patient population	2 years after surgery